Seasoned orphan-drug leader joins OKYO Pharma (NASDAQ: OKYO) as CMO for NCP push
Rhea-AI Filing Summary
OKYO Pharma has appointed Flavio Mantelli, MD, PhD as Chief Medical Officer, adding a seasoned ophthalmology leader to its executive team. He previously led the clinical development, FDA approval and global strategy of Oxervate, an orphan corneal therapy that achieved blockbuster status with sales topping $1 billion in 2024.
At OKYO, Dr. Mantelli will oversee clinical and regulatory strategy, focusing on advancing urcosimod for neuropathic corneal pain and additional orphan indications. Urcosimod has FDA Fast Track designation, the first IND for NCP, compassionate use authorization, positive Phase 2 pain‑reduction data in NCP and earlier efficacy data in dry eye disease. OKYO plans a ~150‑subject Phase 2b/3 multiple‑dose NCP study in the first half of this year.
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Insights
OKYO adds a proven orphan ophthalmology developer to lead its urcosimod program.
OKYO Pharma named Flavio Mantelli, MD, PhD as Chief Medical Officer, emphasizing his record leading Oxervate’s clinical program, FDA approval and global strategy, with Oxervate reaching blockbuster status and sales topping $1 billion in 2024 for a rare corneal disease.
He will guide clinical and regulatory strategy for urcosimod in neuropathic corneal pain and other orphan indications. Urcosimod already holds FDA Fast Track designation, the first IND for NCP, and authorization for compassionate use, alongside positive Phase 2 NCP pain‑reduction data and prior dry eye disease results.
The company plans a ~150 subject Phase 2b/3 multiple‑dose urcosimod trial in NCP in the first half of this year, positioned as a potential pivotal study. Actual outcomes will depend on Phase 2b/3 data quality, regulatory interactions and execution of the broader development strategy under the new CMO’s leadership.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
February 2026
Commission File Number: 001-41386
OKYO Pharma LTD
(Exact Name of Registrant as Specified in Its Charter)
9th Floor
107 Cheapside
London
EC2V 6DN
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On February 10, 2026, OKYO Pharma LTD (the “Company”) issued this 6K announcing the appointment of Flavio Mantelli, MD, PhD as Chief Medical Officer. Dr. Mantelli brings unparalleled experience in ocular surface drug development, having led the clinical development, regulatory approval, and global medical strategy of Oxervate® (cenegermin-bkbj) at Dompé farmaceutici S.p.A. which achieved blockbuster status with sales topping $1 billion in 2024 and is widely considered one of the most successful orphan drug launches in ophthalmology.
The Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, This report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (Reg. No. 333-293145)
| 2 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| OKYO Pharma LTD | ||
| Date: February 10, 2026 | By: | /s/ Keeren Shah |
| Name: | Keeren Shah | |
| Title: | Chief Financial Officer | |
| 3 |
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | News Announcement, dated February 10, 2026 |
| 4 |
Exhibit 99.1
OKYO Pharma Strengthens World Class Leadership Team with Appointment of Flavio Mantelli, MD, PhD as Chief Medical Officer
| ● | Dr. Mantelli, former Chief Medical Officer at Dompé, spearheaded the successful clinical development program and FDA approval of Oxervate®, a blockbuster orphan therapy in corneal disease | |
| ● | Dr. Mantelli will lead the clinical and regulatory strategy to advance the company’s development program in neuropathic corneal pain (NCP), leveraging urcosimod’s FDA Fast Track designation | |
| ● | This appointment, following the recent CEO appointment, further strengthens OKYO’s world-class ophthalmology leadership team |
London and New York, NY, February 10, 2026. OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announced the appointment of Flavio Mantelli, MD, PhD as Chief Medical Officer. Dr. Mantelli brings unparalleled experience in ocular surface drug development, having led the clinical development, regulatory approval, and global medical strategy of Oxervate® (cenegermin-bkbj) at Dompé farmaceutici S.p.A. which achieved blockbuster status with sales topping $1 billion in 2024 and is widely considered one of the most successful orphan drug launches in ophthalmology.
Dr. Mantelli is a highly regarded ophthalmologist with an extensive background in cornea and ocular surface diseases, neurotrophic keratopathy, and inflammatory eye conditions. He brings critical knowledge and experience to OKYO in developing therapeutics from first-in-human studies through to global regulatory approval. As the clinical leader behind the transformation of a novel biologic into a first-in-class, FDA approved topical ophthalmic therapy, he set a new benchmark for orphan drug clinical development for treatments of corneal disease. Dr. Mantelli graduated in Medicine and Surgery summa cum laude from Università Campus Bio-Medico of Rome, where he also completed his residency in ophthalmology and a PhD in regenerative medicine. He further pursued a postdoctoral fellowship in ocular surface glycobiology at the Schepens Eye Research Institute, Harvard Medical School.
In his new role at OKYO Pharma, Dr. Mantelli will oversee the company’s clinical development strategy, including the advancement of urcosimod in planned clinical trials for neuropathic corneal pain and addition orphan indications. He intends to build upon the recent FDA alignment with the proposed Phase 2b/3 design, to help ensure the upcoming trial is positioned as a potential pivotal study to bring this important therapy to patients with no FDA approved therapy.
“Neuropathic corneal pain represents one of the most debilitating and underserved areas in ophthalmology. OKYO Pharma’s focus on differentiated, mechanism-based approaches to inflammatory eye diseases and neuropathic corneal pain resonates strongly with my career-long dedication to translating breakthrough science into approved innovative therapies. The fast-track designation and the recent authorization for compassionate use by FDA for urcosimod in NCP highlights the urgency and potential in this area of high unmet medical need,” said Flavio Mantelli, MD, PhD, Chief Medical Officer of OKYO Pharma. “I am excited to join OKYO and work alongside Robert Dempsey and the entire team to advance urcosimod and the broader portfolio, seeking to ensure our development strategy remains grounded in strong science, regulatory rigor, and a clear focus on improving outcomes for patients and eyecare providers.”
“Subsequent to the release of our Phase 2 data in neuropathic corneal pain, OKYO Pharma has attracted two exceptional leaders in ophthalmology, commencing with the appointment of our CEO, Robert Dempsey, and followed by today’s appointment of Dr. Flavio Mantelli as our Chief Medical Officer,” said Gabriele Cerrone, Chairman and Founder of OKYO Pharma. “Dr. Mantelli’s clinical leadership role and experience in developing Oxervate® into a blockbuster drug with annual sales exceeding $1 billion for a rare eye disease, will be invaluable for OKYO’s development of urcosimod for patients with NCP.”
“Bringing Dr. Mantelli into the executive team is tremendously important as we continue to build a world class organization focused on ocular surface disease,” said Robert Dempsey, CEO of OKYO Pharma. “Dr. Mantelli is an exceptional clinical developer whose leadership of a highly successful orphan drug development program in ophthalmology demonstrates his ability to advance complex corneal programs, capabilities that will be critical as we advance urcosimod forward for neuropathic corneal pain.”
As previously announced, urcosimod was granted the first IND application for the treatment of patients with NCP and was awarded fast track designation by the Food and Drug Administration (FDA). The company expects to initiate a ~150 subject Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.
About Flavio Mantelli, MD, PhD
Dr. Mantelli joins OKYO Pharma from Dompé where he served as the Chief Strategy & Innovation Officer, acting as the key link between the company and external partners, with the goal of promoting groundbreaking research initiatives and assessing new opportunities aligned with industry innovations. Previously he served as Chief Medical Officer and Head of R&D for the Ophthalmology and Neurotrophin platforms, leading all research and clinical development programs in ophthalmology.
Prior to joining Dompé, Dr. Mantelli researched the application of neurotrophins in ophthalmic and neurodegenerative diseases and was an adjunct associate professor of biology at Temple University in Philadelphia, PA. His professional experience includes positions at the IRCCS G.B. Bietti Foundation in Rome as a clinical scientist and as a consultant ophthalmologist at the Campus Biomedico University of Rome and the Cornea and Ocular Surface Unit of the Vita-Salute San Raffaele University of Milan.
Graduating in Medicine and Surgery summa cum laude, Dr. Mantelli completed his residency program in ophthalmology and a PhD at the Campus Bio-Medico University of Rome. He also completed a postdoctoral fellowship in ocular surface glycobiology at the Schepens Eye Research Institute of Massachusetts Eye and Ear at Harvard Medical School in Boston.
About Neuropathic Corneal Pain (NCP)
Neuropathic corneal pain (NCP) is a chronic, often debilitating condition characterized by severe pain and sensitivity of the eyes, and in some cases the face or head. It is thought to result from damage or dysfunction of corneal sensory nerves, often in combination with inflammatory processes, and may occur in patients with a range of underlying ophthalmic conditions. There are currently no FDA-approved therapies specifically for NCP, resulting in patients being treated with limited or no success using various topical and systemic medications in an off-label manner.
About Urcosimod (formerly called OK-101)
Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2a trial involving 18 neuropathic corneal pain patients. Urcosimod has shown significant pain reduction in an earlier 240-patient Phase 2, multi-center, double-masked, placebo-controlled trial in DED, which supports the development rationale in NCP.
About OKYO Pharma
OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases, with ordinary shares listed for trading on the Nasdaq Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in patients with NCP and plans to initiate a ~150 subject Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.
For further information, please visit www.okyopharma.com.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 20-F, for the fiscal year ended March 31, 2025. The company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements, except as may be required by law.
For further inquiries:
OKYO Pharma Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
Email: info@okyopharma.com
FAQ
What did OKYO (OKYO) announce in this Form 6-K filing?
OKYO announced the appointment of Flavio Mantelli, MD, PhD as Chief Medical Officer. He will oversee clinical and regulatory strategy, particularly for urcosimod in neuropathic corneal pain and other orphan eye indications, strengthening the company’s ophthalmology-focused leadership team.
Who is OKYO (OKYO)'s new Chief Medical Officer, Flavio Mantelli?
Flavio Mantelli is an ophthalmologist with deep expertise in corneal and ocular surface diseases. He led Oxervate’s clinical development, FDA approval and global strategy at Dompé, where Oxervate became a blockbuster orphan drug with sales topping $1 billion in 2024 for a rare eye disease.
What is urcosimod and how is OKYO (OKYO) developing it?
Urcosimod is a lipid-conjugated chemerin peptide ChemR23 agonist being developed for neuropathic corneal pain and inflammatory eye diseases. It has shown anti-inflammatory and pain-reducing activity in preclinical models and positive NCP pain reduction in a randomized, placebo-controlled Phase 2a trial involving 18 neuropathic corneal pain patients.
What regulatory designations has OKYO (OKYO) received for urcosimod in NCP?
Urcosimod received the first IND application clearance for treating neuropathic corneal pain and was granted FDA Fast Track designation. The FDA has also authorized compassionate use for urcosimod in NCP, reflecting significant unmet medical need in this debilitating eye pain condition without approved therapies.
What are OKYO (OKYO)'s next clinical plans for urcosimod?
OKYO plans to initiate a ~150 subject Phase 2b/3 multiple-dose study of urcosimod in neuropathic corneal pain in the first half of this year. The trial is designed, following FDA alignment, to potentially serve as a pivotal study aimed at supporting future regulatory approval.
What prior clinical data support OKYO (OKYO)'s urcosimod program?
Urcosimod produced significant pain reduction in a randomized, placebo-controlled, double-masked Phase 2a trial with 18 neuropathic corneal pain patients. Earlier, a 240-patient Phase 2 multi-center, double-masked, placebo-controlled dry eye disease study showed significant pain reduction, supporting its development rationale in NCP.
How does OKYO (OKYO) describe neuropathic corneal pain (NCP)?
Neuropathic corneal pain is described as a chronic, often debilitating condition with severe eye pain and sensitivity, sometimes affecting the face or head. It stems from corneal nerve damage or dysfunction with inflammatory processes, and currently lacks any FDA-approved therapies specifically indicated for NCP.